MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number L331

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2022

Event Type  malfunction  

Event Description

It was reported that the patient implanted with this pacemaker had undergone multiple programming sessions since implant to optimize minute ventilation (mv) sensor and accelerometer (xl) sensor driven pacing due to difficulty raising and raising his heart rate above 60 bpm with activity, especially while using a stationary bike for exercise.Following a stress test and reprogramming on (b)(6) 2023, the device reportedly worked, and then the patient's heart rate jumped from 140 bpm, spiked up to 170 bpm, and then lowered again.Review of remote monitoring data revealed stored pacemaker mediated tachycardia (pmt) episodes, premature ventricular contractions (pvcs), and possible retrograde conduction.In (b)(6) 2023, technical services (ts) discussed troubleshooting options and additional programming considerations, reminding the patient to take deeper and slower breaths.Additional programming changes were peformed in (b)(6) 2024.It was noted that the patient received appropriate rate response while riding upright on the stationary bike, but not when leaning forward while exercising.A request was made to have data from this device analyzed due to the numerous attempts at reprogramming to address the patient's needs.Data analysis indicated that the mv sensor had been disabled (b)(4) of the device's implanted time due ot noise and rythmiq episodes suggested there was av block at higher rates.Ts recommended further evaluation and reprogramming, accounting for these additional factors pertaining to patient's underlying conditions.This pacemaker remains in service.No adverse patient effects were reported.

Manufacturer Narrative

The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient implanted with this pacemaker had undergone multiple programming sessions since implant to optimize minute ventilation (mv) sensor and accelerometer (xl) sensor driven pacing due to difficulty raising his heart rate above 60 bpm with activity, especially while using a stationary bike for exercise.Following a stress test and reprogramming on (b)(6) 2023, the device reportedly worked, and then the patient's heart rate jumped from 140 bpm, spiked up to 170 bpm, and then lowered again.Review of remote monitoring data revealed stored pacemaker mediated tachycardia (pmt) episodes, premature ventricular contractions (pvcs), and possible retrograde conduction.In (b)(6) 2023, technical services (ts) discussed troubleshooting options and additional programming considerations, reminding the patient to take deeper and slower breaths.Additional programming changes were performed in (b)(6) 2024.It was noted that the patient received appropriate rate response while riding upright on the stationary bike, but not when leaning forward while exercising.A request was made to have data from this device analyzed due to the numerous attempts at reprogramming to address the patient's needs.Data analysis indicated that the mv sensor had been disabled 0.04% of the device's implanted time due to noise and rythmiq episodes suggested there was av block at higher rates.Ts recommended further evaluation and reprogramming, accounting for these additional factors pertaining to patient's underlying conditions.This pacemaker remains in service.No adverse patient effects were reported.Additional information received reported that the patient implanted with this pacemaker system was seen for an office visit to undergo retrograde/antegrade conduction testing.The pr interval at rest was 171 ms.Retrograde test results were: 190 ms at 90 beats per minute (bpm), 200 ms at 100 bpm, and 210 ms at 110 bpm; setting the pvarp at 240 ms should cover any retrograde conduction.Antegrade testing revealed blocking at 115 bpm.Rythmiq was turned off, and avsearch was set to 300 ms.Technical services (ts) discussed an increase in rv pacing due to the known heart block at 115 bpm.It was noted that the patient was in atrial fibrillation (af) and sudden brady response (sbr) appear to have been stored appropriately.This pacemaker system remains in service.No adverse patient effects were reported.

Manufacturer Narrative

The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACCOLADE MRI EL DR
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18918842
• MDR Text Key: 337853994
• Report Number: 2124215-2024-15963
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559266
• UDI-Public: 00802526559266
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 543351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Male